LENGTH-ADJUSTABLE OSSICULAR PROSTHESIS HAVING IN-SITU ELONGATION OUT OF THE HEAD PLATE

Abstract

An ossicular prosthesis has a first fastening element for mechanical contact with the tympanic membrane, and a second fastening element for connecting to a member of the ossicular chain, and a connecting element which connects the fastening elements and which has rib elements which can be spread radially outwards and thereby shorten the axial length of the ossicular prosthesis. The rib elements lead directly into coupling regions of the first fastening element and into a coupling element which is rigidly connected to the second fastening element. When a force is introduced in parallel with the longitudinal axis in the direction, the rib elements assume a position located radially further from the longitudinal axis, and shorten the functional length of the prostheses, or increase with the introduction of an antiparallel force.

Claims

1. An ossicular prosthesis (10; 20; 30; 40), which replaces or bridges at least one member or parts of a member of an ossicular chain, the ossicular prosthesis (10; 20; 30; 40) comprising: at one end, a first fastening element (11; 21; 31; 41) formed as a flat head plate configured for mechanical contact with a tympanic membrane and/or with a handle of malleus, at the other end, a second fastening element (12; 22; 32; 42) configured for mechanical connection to a member or parts of a member of the ossicular chain or to the inner ear, and a connecting element (13) that connects the two fastening elements (11, 12; 21, 22; 31, 32; 41, 42) to one another, in a sound-conducting manner, along a longitudinal axis (z), the connecting element (13) having rib elements (14; 24; 34; 44), which are configured to be spread outwards, to a greater or lesser extent, radially away from the longitudinal axis (z), at least sectionally, so as to shorten an axial length of the ossicular prosthesis (10; 20; 30; 40) to a greater or lesser extent, wherein the rib elements (14; 24; 34; 44) lead at the one end directly into coupling regions (15; 25; 35; 45) of the first fastening element (11; 21; 31; 41) within a head plate plane and are movably, but non-detachably, connected thereto, all the rib elements (14; 24; 34; 44) lead directly, at the other end, into a coupling element (16; 26; 36; 46) and are also movably, but non-detachably, connected thereto, the coupling element (16; 26; 36; 46) in turn being rigidly connected at the other end to the second fastening element (12; 22; 32; 42), the rib elements (14; 24; 34; 44) are designed in such a way that, in an in-situ state of the ossicular prosthesis (10; 20; 30; 40) inserted in a human middle ear, when a force is applied to the rib elements (14; 24; 34; 44) with a force component in parallel with the longitudinal axis (z) in a direction from the first fastening element (11; 21; 31; 41) to the second fastening element (12; 22; 32; 42) in each case sectionally assume, in situ, a position located radially further from the longitudinal axis (z), and therefore shorten, in situ, the axial functional length between the first fastening element (11; 21; 31; 41) and the second fastening element (12; 22; 32; 42), each of the rib elements (14; 24; 34; 44), with the introduction of a force having force components that are antiparallel with respect to the longitudinal axis (z), in the direction from the second fastening element (12; 22; 32; 42) to the first fastening element (11; 21; 31; 41) sectionally assuming, in situ, a position located radially closer to the longitudinal axis (z), and therefore increasing, in situ, the axial functional length between the first fastening element (11; 21; 31; 41) and the second fastening element (12; 22; 32; 42), and the rib elements (14, 24; 34; 44) retain, in situ, their adjusted radial position with respect to the longitudinal axis (z), when no force acts.

2. The ossicular prosthesis according to claim 1, wherein the rib elements (14; 24; 34; 44) are designed such that their adjusted radial position relative to the longitudinal axis (z) can be reversibly changed in situ by introducing a corresponding force.

3. The ossicular prosthesis according to claim 1, further comprising locking devices which are configured to cause a mechanical resistance at one or more axial lengths of the connecting element (13) when an axial force is applied to the rib elements (14; 24; 34; 44).

4. The ossicular prosthesis according to claim 1, wherein the coupling regions (15; 25; 35; 45) arranged within the head plate plane of the first fastening element (11; 21; 31; 41) are geometrically designed such that they can be used to apply a force to the rib elements (14; 24; 34; 44) with a force component in parallel or antiparallel with respect to the longitudinal axis (z) by means of an adjusting tool in situ.

5. The ossicular prosthesis according to claim 1, wherein the connection points of the rib elements (14; 24; 34; 44) with the coupling regions (15; 25; 35; 45) of the first fastening element (11; 21; 31; 41) and the connection points of the rib elements (14; 24; 34; 44) with the coupling element (16; 26; 36; 46) are each designed as mechanical joints or bending points.

6. The ossicular prosthesis according to claim 1, wherein the rib elements (14; 24; 34; 44) are designed so as to be mechanically rigid at least sectionally.

7. The ossicular prosthesis according to claim 6, wherein integrated mechanical joints or bending points are formed between the mechanically rigid portions of the rib elements (14; 24; 34; 44).

8. The ossicular prosthesis according to claim 1, wherein the rib elements (14; 24; 34; 44) are formed at least sectionally from a plastic, flexible material, and wherein the plastic, flexible material of the rib elements (14; 24; 34; 44) has an elasticity of 1%, preferably an elasticity of 2%.

9. The ossicular prosthesis according to claim 8, wherein the plastic, flexible material of the rib elements (14; 24; 34; 44) contains highly elastic material in the form of amorphous metal, based on nickel, iron, cobalt or zirconium, and/or a nickel-titanium alloy and/or memory metal.

10. The ossicular prosthesis according to claim 8, wherein the plastic, flexible material of the rib elements (14; 24; 34; 44) contains a highly elastic plastic in the form of a high-strength elastic polymer, and/or elastic ceramic.

11. The ossicular prosthesis according to claim 8, wherein the coupling regions (15; 25; 35; 45), the rib elements (14; 24; 34; 44) and the coupling element (16; 26; 36; 46) are arranged flat within the head plate plane of the first fastening element (11; 21; 31; 41) before the first application of a force to the rib elements (14; 24; 34; 44) with a force component in parallel or antiparallel with respect to the longitudinal axis (z).

12. The ossicular prosthesis according to claim 11, wherein the rib elements (14; 24; 34; 44) extend between their respective coupling region (15; 25; 35; 45) and the coupling element (16; 26; 36; 46) in a curved and/or meandering and/or zigzag manner.

13. The ossicular prosthesis according to claim 11, wherein the coupling element (16; 26; 36; 46) has a ring-shaped design and is arranged centrally in the first fastening element (11; 21; 31; 41) in an initial position within the head plate plane.

14. A system comprising an ossicular prosthesis (10; 20; 30; 40) according to claim 1, and an adjusting tool configured to adjust a force component of the force applied to the rib elements by the coupling regions between parallel and antiparallel with respect to the longitudinal axis (z), wherein the adjusting tool is designed as a minimally invasive endoscopic instrument,

15. The system according to claim 14, wherein the adjusting tool is designed tweezer-like or pincer-like.

16. A method for implantation of an ossicular prosthesis (10; 20; 30; 40) according to claim 1, wherein the coupling regions (15; 25; 35; 45) within the head plate plane of the first fastening element have structures made of memory metal, and wherein the method comprises applying a force to the rib elements (14; 24; 34; 44) by heating the structures made of memory metal, with resulting deformation of the structures.

17. The method according to claim 16, wherein the heating takes place in a contactless manner by light irradiation.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0072] Other objects and features of the invention will become apparent from the following detailed description considered in connection with the accompanying drawings. It is to be understood, however, that the drawings are designed as an illustration only and not as a definition of the limits of the invention.

[0073] In the drawings,

[0074] FIG. 1A) to FIG. 1D) show four illustrations of a schematic three-dimensional view of a first embodiment of the ossicular prosthesis according to the invention, of which three illustrations are in an oblique view from above with viewing direction from the second to the first fastening element, the rib elements being extended:

[0075] FIG. 1A) only very little,

[0076] FIG. 1B) a moderate amount,

[0077] FIG. 1C) virtually completely in the z-direction from the head plate plane, and a fourth illustration:

[0078] FIG. 1D) showing a lateral view of the ossicular prosthesis in a viewing direction slightly obliquely from below onto the head plate;

[0079] FIG. 2A) to FIG. 2C) shows a further embodiment of a head plate designed according to the invention, namely:

[0080] FIG. 2A) with a slightly oblique view towards the ossicular prosthesis in the viewing direction from the second to the first fastening element, the rib elements still being arranged completely in the head plate plane before an axial force is introduced,

[0081] FIG. 2B) like FIG. 2A) but with slightly extended rib elements,

[0082] and

[0083] FIG. 2C) the head plate belonging to this embodiment, viewed in the z direction from above;

[0084] FIG. 3 shows a further embodiment of an ossicular prosthesis designed according to the invention, in which the connecting element between the first and second fastening elements comprises two parallel rigid shaft pieces; and

[0085] FIG. 4 shows an embodiment of an ossicular prosthesis according to the invention in which the first fastening element is designed as a divided head plate in two parallel planes perpendicular to the z-axis, the connecting element between the first and second fastening elements in each case comprising a shaft piece running in each of the two head plate planes.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0086] The embodiments of the ossicular prosthesis 10; 20; 30; 40 (or parts thereof) according to the invention, shown schematically in the figures of the drawing, each comprise a first fastening element 11; 21; 31; 41 at one end, which is designed in the form of a flat head plate for mechanical contact with the tympanic membrane and/or with the handle of malleus. At the other end of the ossicular prosthesis 10; 20; 30; 40 sits a second fastening element 12; 22; 32; 42 for mechanically connecting the prosthesis to a member or parts of a member of the ossicular chain or to the inner ear. A connecting element 13 which connects the two fastening elements 11, 12 or 21, 22 or 31, 32 or 41 to one another in a sound-conducting manner along a longitudinal axis z, and which in some embodiments can be designed in the form of ausually elongateshank, is arranged therebetween.

[0087] The connecting element 13 comprises rib elements 14; 24; 34; 44 which, at least sectionally, can be spread, to a greater or lesser extent, radially outwards from the longitudinal axis z, and thereby shorten the axial length of the ossicular prosthesis 10; 20; 30; 40 to a greater or lesser extent.

[0088] In comparison to known generic ossicular prostheses, the invention is characterized in that the rib elements 14; 24; 34; 44 lead at one end directly into coupling regions 15; 25; 35; 45 of the first fastening element 11; 21; 31; 41 within the head plate plane and are movably, but non-detachably, connected thereto, [0089] in that all the rib elements 14; 24; 34; 44 lead directly, at the other end, into a coupling element 16; 26; 36; 46 and are also movably, but non-detachably, connected thereto, the coupling element 16; 26; 36; 46 in turn being rigidly connected at the other end to the second fastening element 12; 22; 32; 42, [0090] in that the rib elements 14; 24; 34; 44, in an in-situ state of the ossicular prosthesis 10; 20; 30; 40 inserted in a human middle ear, when a force is applied to the rib elements 14; 24; 34; 44 with the force component in parallel with the longitudinal axis z in the direction from the first fastening element 11; 21; 31; 41 to the second fastening element 12; 22; 32; 42, in each case sectionally assume, in situ, a position located radially further from the longitudinal axis z, and therefore shorten, in situ, the axial functional length between the first fastening element 11; 21; 31; 41 and the second fastening element 12; 22; 32; 42, the rib elements 14; 24; 34; 44, with the introduction of a force having force components that are antiparallel with respect to the longitudinal axis z, in the direction from the second fastening element 12; 22; 32; 42 to the first fastening element 11; 21; 31; 41, in each case sectionally assuming, in situ, a position located radially closer to the longitudinal axis z, and therefore increasing, in situ, the axial functional length between the first fastening element 11; 21; 31; 41 and the second fastening element 12; 22; 32; 42, [0091] and in that the rib elements 14, 24; 34; 44 retain, in situ, their adjusted radial position with respect to the longitudinal axis z, when no force acts.

[0092] The three views FIG. 1A) to FIG. 1C) show the ossicular prosthesis 10 in three different operating positions, namely: [0093] FIG. 1A) in an only very slightly extended state of the rib elements 14, in which said rib elements are still arranged virtually in the head plate plane of the first fastening element 11, [0094] FIG. 1B) having a moderate extension path of the rib elements 14 and correspondingly enlarged functional length of the prosthesis between the first fastening element 11 and the second fastening element 12, and [0095] FIG. 1C) having rib elements 14 extending fully in the z-direction, out of the head plate plane.

[0096] The fourth view FIG. 1D) shows the ossicular prosthesis 10 laterally obliquely from below, with a viewing direction from the second fastening element 12 to the first fastening element 11, in a semi-extended state of the rib elements 14 (such as in FIG. 1B)). Here, the coupling element 16 can be clearly seen.

[0097] The two first views FIG. 2A) and FIG. 2C) show two operating positions of a further embodiment of the ossicular prosthesis 20 according to the invention, namely: [0098] FIG. 2A) having rib elements 24 still arranged completely in the head plate plane prior to the introduction of an axial force, and [0099] FIG. 2B) having helically designed rib elements extended somewhat in the z-direction, after an axial force has been introduced.

[0100] The third view FIG. 2C) shows the head plate 21 belonging to this embodiment with a plan view from above in the z-direction.

[0101] FIG. 3 shows a further embodiment of an ossicular prosthesis 30 designed according to the invention, in which the connecting element between the first fastening element 31 and the second fastening element 32 comprises two rigid shaft pieces extending in parallel with the z-axis. One end of these two shaft pieces is used here as a coupling element 36, into which the annular rib elements 34 lead at their end facing the second fastening element 32, proceeding from their respective coupling region 35 in the first fastening element 31.

[0102] FIG. 4 finally shows a further variant of an ossicular prosthesis 40 according to the invention, in which the first fastening element 41 is designed as a divided head plate in two parallel planes. The connecting element between the first fastening element 41 and the second fastening element 42 in turn comprises two parallel shaft pieces, the two shaft pieces having different lengths in the z-direction, however, due to the axial distance between the two halves of the first fastening element 41. Here too, the end of these two shaft pieces facing the first fastening element 41 serves in each case as a coupling element 46 for the rib elements 44, proceeding from their respective coupling region 45 in the first fastening element 41. In the second fastening element 42, both shaft pieces then end at the same axial height.

[0103] Although only a few embodiments of the present invention have been shown and described, it is to be understood that many changes and modifications may be made thereunto without departing from the spirit and scope of the invention.

LIST OF REFERENCE SIGNS

[0104] 10; 20; 30; 40 ossicular prosthesis [0105] 11; 21; 31; 41 first fastening element [0106] 12; 22; 32; 42 second fastening element [0107] 13 connecting element [0108] 14; 24; 34; 44 rib elements [0109] 15; 25; 35; 45 coupling regions [0110] 16; 26; 36; 46 coupling element [0111] Z longitudinal axis

LIST OF REFERENCES

[0112] Publications considered for the assessment of patentability: [0113] [1] U.S. Pat. No. 10,687,937 B2 [0114] [2] DE 42 10 235 C1; EP 0 809 982 B1; U.S. Pat. No. 6,387,128 B1 [0115] [3] EP 1 181 907 B1 [0116] [4] US 2004/0162614 A1 [0117] [5] EP 1 833 424 B1 [0118] [6] EP 1 972 307 B1 [0119] [7] EP 3 311 773 B1 [0120] [8] DE 10 2007 041 539 B4 [0121] [9] EP 2 238 946 B1 [0122] [10] EP 2 601 909 B1 [0123] [11] EP 3 130 315 B1 [0124] [12] EP 1 961 400 B1